Overview of creating an integrated protocol

Using the CIS application, you can create a Clintrial protocol through the CIS software from integrated metadata and then perform the additional configuration required for EDC and hybrid integrated studies.

The first time that synchronization occurs in an integrated clinical study, the study metadata and mapping information are sent with the data to the Clintrial server. If a protocol for the study does not exist, it is automatically created. During subsequent synchronization transactions, updates to both metadata and clinical data are automatically propagated to the existing Clintrial protocol, along with audit and query information.

Note: The CIS software cannot delete a Clintrial protocol.